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Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
This study is currently recruiting participants.
Verified October 2016 by Wendy Landier, University of Alabama at Birmingham
Sponsor:
University of Alabama at Birmingham
Collaborators:
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wendy Landier, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01492582
First received: December 12, 2011
Last updated: October 6, 2016
Last verified: October 2016
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Purpose
This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.
| Condition | Intervention | Phase |
|---|---|---|
| Cancer Survivor Prevention of Human Papillomavirus Infection | Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) Other: laboratory biomarker analysis Other: survey administration Other: medical chart review | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial |
Resource links provided by NLM:
Further study details as provided by Wendy Landier, University of Alabama at Birmingham:
Primary Outcome Measures:
- Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ]To estimate the prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years and to examine the sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
- Immunogenicity of the HPV vaccine in cancer survivors (anti-HPV 6 and 11 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ]To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
- Safety/tolerability of the HPV vaccine in cancer survivors (Aim 2 [vaccine evaluation]) [ Time Frame: Through 7-14 days following last vaccine dose ]To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population
| Estimated Enrollment: | 1268 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prevention (vaccine therapy)
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)
Given IM
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: survey administration
Ancillary studies
Other: medical chart review
Ancillary studies
Other Name: chart review
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.
III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.
OUTLINE:
AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
Eligibility| Ages Eligible for Study: | 9 Years to 26 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- AIM 1 (SURVEY) (AIM 1 is closed to enrollment)
- Cancer survivor
- Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant [HCT])
- Scheduled for a return clinic visit at one of the participating institutions
- English or Spanish-speaking
- Willing to provide informed consent/assent for study participation
- AIM 2 (VACCINE EVALUATION)
- Meets all inclusion criteria outlined in Aim 1
- Survey response indicated no prior history of HPV vaccination OR patient has no prior history of HPV vaccination by self - or parent/caregiver-report
- English or Spanish-speaking
- Medical clearance from treating clinician for study participation
- Agrees to return to participating institution for 3 HPV vaccine injections
- Willing to provide informed consent/assent for study participation
Exclusion Criteria:
- AIM 2 (VACCINE EVALUATION)
- Allergy to any component of the HPV vaccine including yeast and aluminum
- Thrombocytopenia (platelet count < 50K) or coagulation disorder that would contraindicate intramuscular injection
- Transfusion of blood products or intravenous immune globulin within 3 months of study entry
- Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492582
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492582
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Wendy Landier, PhD, CRNP 205-638-2120 wlandier@peds.uab.edu | |
| Principal Investigator: Wendy Landier, PhD, CRNP | |
| United States, California | |
| City of Hope Medical Center | Active, not recruiting |
| Duarte, California, United States, 91010 | |
| United States, Georgia | |
| Emory University School Of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Karen Wasilewski-Masker, MD 404-536-5747 karen.wasilewski@choa.org | |
| Principal Investigator: Karen Wasilewski-Masker, MD | |
| United States, Michigan | |
| University of Michigan | Active, not recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: James Klosky, PhD 901-595-5057 james.klosky@stjude.org | |
| Principal Investigator: James Klosky, PhD | |
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | Wendy Landier, PhD, CRNP | University of Alabama at Birmingham |
More Information
| Responsible Party: | Wendy Landier, Principal Investigator, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01492582 History of Changes |
| Other Study ID Numbers: |
UAB-F141204009/UAB-X141204010 NCI-2011-03654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 1R01CA166559 ( U.S. NIH Grant/Contract ) Merck-IISP#40083 ( Other Identifier: Merck & Co. ) COH-11034 ( Other Identifier: City of Hope IRB ) |
| Study First Received: | December 12, 2011 |
| Last Updated: | October 6, 2016 |
Additional relevant MeSH terms:
|
Infection Papillomavirus Infections DNA Virus Infections Virus Diseases |
Tumor Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 24, 2017